510(k) Report

Devices descending from K071141

2 later devices reach BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150815BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitBecton, Dickinson and Company201501
+1K081213BD Facscount CD4 Reagents with Model 339010Bd Biosciences200802